(20 days)
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No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related computational processing.
No.
The device is a headless compression screw used for fracture fixation, reconstruction, osteotomy, and arthrodesis, which are surgical interventions rather than therapeutic treatments in the context of this device. Manufacturing materials include stainless steel and titanium alloy.
No
Explanation: The device is a surgical screw indicated for fracture fixation and reconstruction, not for diagnosing medical conditions.
No
The device description clearly describes physical hardware components (screws made of stainless steel and titanium alloy) and their physical characteristics (cannulated, self-drilling/self-tapping, StarDrive recess, threaded head). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device description: The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are implants used for fracture fixation, reconstruction, osteotomy, and arthrodesis of bones. They are physically inserted into the body to stabilize bone structures.
- Intended Use: The intended use clearly describes a surgical procedure involving the fixation of bones, not the analysis of biological samples.
Therefore, based on the provided information, the Synthes 4.5 mm and 6.5 mm Headless Compression Screws are surgical implants, not IVDs.
N/A
Intended Use / Indications for Use
The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Product codes
HWC
Device Description
Synthes 4,5 mm and 6,5 mm Headless Compression Screws are cannulated and are self-drilling/self tapping, feature a StarDrive recess, and have a threaded head which can be countersunk into the bone. They are available in stainless steel and titanium alloy, in a variety of lengths.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes 4.5 mm Cannulated Screws, Synthes 6.5 mm Cannulated Screws, OsteoMed's Headless Cannulated Screw System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Summary Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 APR 2 3 2008 (610) 719-6940 Sheri L. Musgnung Contact: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6940 FAX (610) 484-356-9682 Device Name: Synthes 4.5 mm and 6.5 mm Headless Compression Screws Classification; Class II, §888.3040 - Smooth or threaded metallic bone fixation fastener. Predicate Device: Synthes 4.5 mm Cannulated Screws Synthes 6.5 mm Cannulated Screws OsteoMed's Headless Cannulated Screw System Device Description: Synthes 4,5 mm and 6,5 mm Headless Compression Screws are cannulated and are self-drilling/self tapping, feature a StarDrive recess, and have a threaded head which can be countersunk into the bone. They are available in stainless steel and titanium alloy, in a variety of lengths. Intended Use: The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia. Substantial Information presented supports substantial equivalence. Equivalence:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2008
Synthes (USA) % Ms. Sheri Musgnung 1301 Goshen Parkway West Chester, PA 19380
Re: K080943 Trade/Device Name: Synthes 4.5 mm and 6.5 mm Headless Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 2, 2008 Received: April 3, 2008
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Sheri Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K080943 510(k) Number (if known): Synthes 4.5 mm and 6.5 mm Headless Compression Screws Device Name: Indications for Use; The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intraarticular fractures of the humerus, femur and tibia. Over-The-Counter Use X AND/OR Prescription Use (21 CFR 807 Subpart C) (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogle for nxn
(Division Si Division of General, Restorative, and Neurological Devices
510(k) Number K080943
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